Pregnancy and OTC Cough, Cold, and Analgesic Preparations

First Trimester Second Trimester Third Trimester Pregnancy week by week Pregnancy showers Best of baby list

Baby

Toddler

Toddler Month by Month

Baby names

View all Topics

Tools

News

Community

Account & more

Ashley Roman, MD

OB-GYN

Over-The-Counter Medications You Can Take While Pregnant

Colds, coughs or congestion are never fun, but they’re even worse when you’re pregnant. Here’s what medicine you can safely take to feel better faster.

Aches, pains and uncomfortable symptoms are unfortunately part and parcel of pregnancy. But before you reach for that over-the-counter medicine, learn which medications are safe to take during pregnancy, and which are not.

Many over-the-counter medications are safe to use in pregnancy, but there are a few surprising drugs that can lead to problems for baby. In general, always speak with your doctor prior to taking any medication (prescription, over-the-counter or herbal/homeopathic) and always follow the dosage instructions on the package.

Keep in mind that certain vague symptoms you wouldn’t think twice about in normal times (a headache, for example) can sometimes be a sign of a more serious pregnancy-related complication. And before taking any over-the-counter medication, think about what other medications you are taking. Even medications that are considered safe in pregnancy can become dangerous when they interact with others. If you’re not sure, always check in with your ob-gyn.

Here are some common pregnancy problems, along with a quick summary of related medicines that are probably safe—and ones that probably aren’t.

Aches and painsAcetaminophen (Tylenol) is okay to take for treating general aches, pains and headaches . But you want to steer clear of NSAIDS (non-steroidal anti-inflammatory drugs), which include ibuprofen (Advil and Motrin) and naproxen (Aleve). These OTC drugs may be associated with congenital heart defects when taken during the first trimester. They’ve also been linked to other heart abnormalities and low amniotic fluid levels when used in the third trimester.

Congestion and allergy symptomsFor congestion issues , antihistamines such as diphenhydramine (Benadryl) and loratidine (Claritin) appear to be safe during pregnancy. Avoid pseudoephedrine (Sudafed), since it may be associated with birth defects involving baby’s abdominal wall. Also, decongestants (such as phenylephrine) may affect blood flow to the placenta and should generally be avoided throughout your pregnancy.

CoughTwo major cough medication ingredients—dextromethorphan (a cough suppressant) and guaifenesin (an expectorant, which means it loosens up thick mucus)—both appear to be safe during pregnancy, although both have been tested in relatively few studies.

ConstipationTo help ease constipation , both Metamucil and stool softeners like Colace appear to be safe in pregnancy. Laxatives, mineral oils and rectal suppositories may stimulate labor, so these should only be used after speaking with your doctor.

HeartburnAntacids such as Tums and Mylanta appear to be safe in pregnancy, and for most women, they significantly improve heartburn symptoms . If antacids aren’t enough though, famotidine (Pepcid) and andranitidine (Zantac) do not appear to be associated with any pregnancy complications.

All this said, there are situations where the potential benefit of taking a medication outweighs any potential risk to baby. The most important piece of advice regarding medication is to talk with your doctor! Be honest about your questions, concerns and medical history and you should be just fine.

related video

Safe Medications During Pregnancy

Share

Sms

Tweet

Email

Share

Tweet

Copy Link

Email

About Us and Contact Advertise With Us Jobs Privacy Policy Terms of Use

Is Phenylephrine Safe to Use During Pregnancy?

Medically reviewed by Zara Risoldi Cochrane, PharmD, MS, FASCP on July 18, 2016 — Written by University of Illinois-Chicago, Drug Information Group

Effects on pregnancy

Interactions

Side effects

Forms of phenylephrine

Alternatives

Takeaway

Introduction

Phenylephrine is a decongestant used for short-term relief of nasal congestion from the common cold, sinusitis, upper respiratory allergies, or hay fever. Phenylephrine is found in several different over-the-counter medications. If you’re pregnant, you’re probably wary of taking many drugs. But what happens if you get a cold or have allergies — can you take a drug like phenylephrine to feel better?

Effects of phenylephrine on pregnancy

Phenylephrine may not be the best choice during pregnancy, especially for women in their first trimester. This is because phenylephrine may cause harm such as birth defects. However, the form of phenylephrine that you use can make a difference.

Get answers: What happens during the trimesters of pregnancy? »

Research suggests that phenylephrine that’s taken by mouth is not safe for pregnant women. This is because of the way phenylephrine works. The drug relieves nasal congestion by narrowing the blood vessels in your nasal passages. This reduces the secretions in the nasal passages and opens up the airways. However, for oral phenylephrine, this narrowing of blood vessels is not limited to the nasal passages. It also affects the blood vessels in your uterus. Any narrowing of uterine blood vessels during pregnancy may decrease the blood flow to the fetus. And decreased blood flow can prevent the fetus from getting enough oxygen, which can cause birth defects or make the baby’s heart beat too slowly. Because of this risk, you should not take oral phenylephrine during pregnancy.

On the other hand, intranasal phenylephrine mostly affects just the nasal passages. You take an intranasal drug directly into the nose, typically by a spray. In general, intranasal decongestants should only be used for three days at a time. There is no known link between short-term use of intranasal phenylephrine and birth defects or other harm to a pregnancy.

However, if you’re pregnant, you should be sure to talk to your doctor before using either form of phenylephrine.

Drug interactions

Oral phenylephrine can interact with some medications that a pregnant woman may be given before, during, and after labor. Oxytocics and ergot derivatives are two classes of these medications. These drugs are used for things such as managing labor and treating postpartum bleeding. Taking these drugs while also taking phenylephrine by mouth can increase blood pressure in the mother, which can cause pregnancy complications or cause the baby to be born too early. These effects are not linked with use of intranasal forms of phenylephrine, however.

Side effects of phenylephrine

Phenylephrine may cause some side effects. These are important to consider during pregnancy when your comfort and your baby’s health are primary concerns. Some of the side effects may go away as your body gets used to the medication. If any of these side effects cause problems for you or don’t go away, call your doctor.

The more common side effects of phenylephrine can include:

nervousness

dizziness

trouble sleeping

burning, stinging, or sneezing right after you use the nasal spray

Serious side effects are usually caused by swallowing the intranasal product by accident. Some serious side effects can include:

nausea

vomiting

drooling

increased temperature

tiredness

coma

OTC drugs containing phenylephrine

Many over-the-counter (OTC) medications contain phenylephrine. Because of the risks during pregnancy, you should know which products contain this ingredient so you can avoid them as needed. Examples of oral drugs that contain phenylephrine include:

Sudafed PE (all versions)

Tylenol Sinus + Headache

Contac Cold + Flu

Mucinex Fast-Max Cold, Flu & Sore Throat

Examples of intranasal drugs that contain phenylephrine include:

Neo-Synephrine (all versions)

4 Way

There are also many generic-version products that contain phenylephrine. These products may combine phenylephrine with other drugs such as guaifenesin (which loosens mucus) and dextromethorphan (a cough suppressant). Be sure to read the labels of any OTC medications you take so you know exactly what drugs you’re using.

Alternative treatments

Symptoms of nasal congestion due to the common cold or allergies can be uncomfortable and unpleasant, but they’re not life-threatening. And over time, they generally go away on their own. For these reasons, many doctors suggest non-drug treatment for nasal congestion during pregnancy. Some options include:

increased fluid intake: helps flush cold viruses out of the body

rest: helps the body fight off illness

hot showers or vaporizers: provide steam to help clear nasal passages

humidifiers: add moisture to the air and help your sinuses drain

Read more: Treating a cold or flu when pregnant »

Talk with your doctor

If you’re pregnant, it’s wise to be careful about which medications you take. The following steps can help:

Talk with your doctor before taking any medications. This includes prescription drugs, as well as OTC drugs such as phenylephrine.

Carefully read the product labels of any cough and cold medications you may want to use. Some of these products may contain phenylephrine or other drugs that may not be safe during pregnancy.

Talk with your doctor if your congestion or other symptoms last longer than a few days. Extended symptoms may mean you have a more serious issue.

Working with your doctor can help you treat your congestion symptoms while keeping your pregnancy safe.

Q:

What’s the difference between phenylephrine and pseudoephedrine?

A:

Both of these drugs are decongestants. Because they do the same thing, they’re not used together in combination medications. However, they are used in different forms of Sudafed. For instance, Sudafed Congestion contains pseudoephedrine, but Sudafed PE Congestion contains phenylephrine. Pseudoephedrine can be made into illegal methamphetamine, a highly addictive drug. Because of this, U.S. law dictates that Sudafed can only be purchased directly from pharmacy staff. That’s why you can’t find regular Sudafed on the pharmacy shelf, but you can find Sudafed PE there.

Healthline Medical TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

Medically reviewed by Zara Risoldi Cochrane, PharmD, MS, FASCP on July 18, 2016 — Written by University of Illinois-Chicago, Drug Information Group

related stories

Chamomile Tea While Pregnant: Is It Safe?

The Ramzi Theory: Is It for Real?

Should I Take Unisom During Pregnancy?

Pregnancy Lingo: What Does Gestation Mean?

Tokophobia: The Women with an Extreme Fear of Pregnancy and Childbirth

READ THIS NEXT

Chamomile Tea While Pregnant: Is It Safe?

If you're pregnant, not all teas are safe to drink. Chamomile is a type of herbal tea. You might like to enjoy a soothing cup of chamomile tea on…

READ MORE

The Ramzi Theory: Is It for Real?

Some people believe the Ramzi theory can determine fetal sex as early as 6 weeks into pregnancy. But only one study has looked at this theory, so…

READ MORE

Should I Take Unisom During Pregnancy?

Here's what you need to know about taking Unisom and other sleep aids during pregnancy.

READ MORE

Pregnancy Lingo: What Does Gestation Mean?

If you're pregnant, you might hear the word "gestation" quite often. Here, we'll define what that word means as well as discuss some similar terms…

READ MORE

Tokophobia: The Women with an Extreme Fear of Pregnancy and Childbirth

For women who haven't given birth before, pregnancy and childbirth is the great unknown. But some women develop a true phobia of birth, known as…

READ MORE

How to Dilate Faster During Labor: Is It Possible?

As you approach your due date and delivery, you might be wondering how to speed up the process. Here's what you need to know about inducing labor and…

READ MORE

7 Nutritious Fruits You’ll Want to Eat During Pregnancy

Fruit is a healthy choice to eat throughout your pregnancy. Here are benefits and ideas for how to add more fruit to your diet.

READ MORE

When Labor Will Start if You're 1 Centimeter Dilated

During late pregnancy, your doctor will check how you're progressing. Here's when you might go into labor if you're 1 centimeter dilated.

READ MORE

What Do Different Types of Labor Contractions Feel Like?

If you're a first-time mom, you might be wondering what contractions feel like. Here's a guide to contractions and how to tell if you're in labor.

READ MORE

8 DPO: The Early Pregnancy Symptoms

If you miss your period, you might wonder if you're pregnant. Some women have symptoms of pregnancy as early as eight days past ovulation (8 DPO). We…

Article Sections

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Many pregnant women take over-the-counter (OTC) medications despite the absence of randomized controlled trials to guide their use during pregnancy. Most data come from case-control and cohort studies. In 1979, the U.S. Food and Drug Administration began reviewing all prescription and OTC medications to develop risk categories for use in pregnancy. Most OTC medications taken during pregnancy are for allergy, respiratory, gastrointestinal, or skin conditions, as well as for general analgesia. Acetaminophen, which is used by about 65% of pregnant women, is generally considered safe during any trimester. Cold medications are also commonly used and are considered safe for short-term use outside of the first trimester. Many gastrointestinal medications are now available OTC. Histamine H2 blockers and proton pump inhibitors have not demonstrated significant fetal effects. Nonsteroidal anti-inflammatory drugs are generally not recommended in pregnancy, especially during organogenesis and in the third trimester. There is even fewer data regarding use of individual herbal supplements. Ginger is considered safe and effective for treating nausea in pregnancy. Topical creams are considered safe based on small studies and previous practice. All OTC medication use should be discussed with patients, and the effects of the symptoms should be balanced with the risks and benefits of each medication. Because of the expanding OTC market, formalized studies are warranted for patients to make a safe and informed decision about OTC medication use during pregnancy.

More than 90% of pregnant women take a prescription or over-the-counter (OTC) medication. 1 Although there are no randomized controlled trials to guide the use of OTC medications during pregnancy, women often use them for skin, allergy, respiratory, and gastrointestinal conditions in addition to general analgesia. All physicians caring for reproductive-aged women should be familiar with the indications, risks, and benefits of OTC medications in pregnancy. Given limited data on the variety of OTC medications available, physicians need to counsel pregnant women about potential risks, and it is beneficial to discuss all OTC medications the patient is taking at the preconception visit and all other routine visits. Table 1 lists online resources for more information about OTC medication use during pregnancy.

Enlarge Print

SORT: KEY RECOMMENDATIONS FOR PRACTICE

Clinical recommendation

Evidence rating

References

First- and second-generation antihistamines do not appear to increase fetal risk in any trimester.

B

5 – 9

Acetaminophen as a single agent does not increase fetal risk in any trimester and is considered safe for use in pregnancy.

B

28 , 31 , 32 , 35

Use of nonsteroidal anti-inflammatory drugs during pregnancy has potential risks. The risk-benefit ratio is best determined with physician consultation.

C

29 , 36 – 39

Histamine H2 blockers and proton pump inhibitors can be used during any trimester of pregnancy without risk of anomalies.

Since 1979, a standard five-letter nomenclature developed by the U.S. Food and Drug Administration (FDA) has been used to assign a pregnancy risk category to prescription and OTC medications ( Table 2 ). 2 In response to ongoing criticism of the confusing and simplistic nature of this system, in 2011, the FDA proposed a new rule for labeling that aims to provide more detailed safety data about use in pregnancy and in turn improve clinical decision making. 3 The new rule divides information into pregnancy and breastfeeding categories, each with the subcategories of risk summary, clinical considerations, and data. The five-letter system and the new system are both currently available.

Enlarge Print

Table 2.

U.S. Food and Drug Administration Pregnancy Risk Categories for Medications

Category

Definition

A

Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of risk in later trimesters, and the possibility of fetal harm appears remote.

B

Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).

C

Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

D

There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

X

Studies in animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Information from reference 2 .

Table 2.

U.S. Food and Drug Administration Pregnancy Risk Categories for Medications

Category

Definition

A

Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of risk in later trimesters, and the possibility of fetal harm appears remote.

B

Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).

C

Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

D

There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

X

Studies in animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Information from reference 2 .

OTC medications that are not available as a prescription often do not get safety ratings, and the FDA website is not often updated after a product has initial approval. Multiple websites and databases with conflicting data make counseling women more difficult. Using the lowest dose for the shortest period possible and trying to avoid medication use during the first trimester are reasonable approaches.

Antihistamines

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Up to 15% of women use an antihistamine during pregnancy to treat allergic rhinitis or nausea. 4 Studies consistently show no significant risk of fetal malformations with first-generation antihistamines, and these agents are considered safe. 5 – 8 The second-generation antihistamines loratadine (Claritin), cetirizine (Zyrtec), and fexofenadine (Allegra) do not appear to increase overall fetal risk. Four studies (n = 1,290) did not find significant fetal risk with cetirizine use. 5 , 9 A slightly higher incidence of hypospadias with loratadine use was shown in one study (n = 1,700), but not in others (n = 2,147). 5 , 8 Fexofenadine has been associated with early pregnancy loss in animal studies but has not been studied in human pregnancy. Fexofenadine is a metabolite of terfenadine, which was removed from the market in 1998 because of a risk of cardiotoxicity. Studies (n = 2,195) on the safety of terfenadine in human pregnancy did not show a significant risk of congenital malformation. 5

Data addressing the safety of topical antihistamines in pregnancy are limited to a single study of the ophthalmic agent pheniramine, which is contained in several OTC combinations with naphazoline. No significant malformations were observed in 831 women who used the medication in the first trimester. 5 There are no data for other topical antihistamines, such as those in anti-itch creams; however, significant fetal risk is unlikely because of the lack of systemic absorption. Table 3 summarizes the safety of antihistamines in pregnancy. 10 – 16

Enlarge Print

Table 3.

Safety of Over-the-Counter Antihistamines, Decongestants, and Expectorants in Pregnancy

Behind-the-counter purchase; possible association with gastroschisis, small intestinal atresia, and hemifacial microsomia; should be avoided in first trimester

Guaifenesin

Expectorant

C

Not known

Safety not established, should be avoided in first trimester

Dextromethorphan

Nonnarcotic antitussive

C

Not known

Appears to be safe in pregnancy

*—Based on pregnancy risk category definitions from the U.S. Food and Drug Administration (Table 2) and other sources.

†—Based on animal data and on human data in term pregnancies. 11 , 12

Information from references 10 through 16 .

Decongestants

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Nearly one in four pregnant women seeks relief from nasal congestion caused by upper respiratory tract infection, allergic rhinitis, or the common phenomenon known as pregnancy rhinitis. 4 The safety of oral phenylephrine in pregnancy has not been established. Data that are now about a decade old (n = 2,730) show an increased risk of congenital malformation (relative risk = 0.6 to 1.2) and of eye, ear, and minor limb malformations (relative risk = 2.7) with phenylephrine use during pregnancy. 11 , 12 , 17 Pseudoephedrine was previously considered low risk in pregnancy based on older cohort studies (n = 1,724) demonstrating no significant teratogenicity. 12 However, its safety was brought into question after recent case-control studies observed small associations between pseudoephedrine and birth defects, including gastroschisis, small intestinal atresia, and hemifacial microsomia. 12 , 17 – 20 The studies are limited by small sample size; retrospective analysis; and potential for confounding factors, such as recall bias. Risk of ventricular septal defects or limb malformations has been observed with decongestants but have not been substantiated. 17 , 21 , 22

Two studies (n = 5,400) show a decreased risk of preterm birth, low birth weight, and preterm labor among women using a variety of oral decongestants in pregnancy. 23 , 24 There are only a few studies on the safety of topical (nasal and ophthalmic) decongestants, none of which demonstrate increased fetal risk. 6 , 19 , 20

Overall, available evidence suggests that decongestants (and combination formulations) should be used sparingly in pregnancy, particularly in the first trimester; however, further study is needed. Saline nasal sprays and adhesive nasal strips are safe OTC alternatives for treating nasal congestion. Table 3 summarizes the safety of decongestants in pregnancy. 10 – 16

Expectorants and Antitussives

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Few studies have addressed the safety of using cough medications during pregnancy. The expectorant guaifenesin has been weakly associated with neural tube defects and inguinal hernias. However, the evidence is not sufficient to determine its safety in pregnancy. It may be prudent to avoid this medication in the first trimester unless the potential benefits outweigh the risks. 25 Table 3 summarizes the safety of expectorants in pregnancy. 10 – 16

Dextromethorphan is a nonnarcotic antitussive isomer of codeine that was found to be teratogenic in chicken embryos. However, a human epidemiologic study and a smaller controlled study did not demonstrate elevated risks of congenital malformations. 26

Analgesics and Antipyretics

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

There are no prospective randomized controlled trials to determine the safety of acetaminophen, ibuprofen, or naproxen use in pregnancy. At least two-thirds of women use acetaminophen during pregnancy, and one-half of these women use it in the first trimester. 1 , 4 , 27 Animal studies suggest that acetaminophen may decrease the diameter of the ductus arteriosus, but experimental conditions prevent reasonable extrapolation to humans. 28 More recent studies have looked at chronic acetaminophen use during pregnancy and the risk of tetralogy of fallot, but no definitive connection has been made. 29 There is conflicting evidence about the risk of gastroschisis, leukemia, and asthma with acetaminophen use. 30 A Danish prospective population-based study (n = 88,142) showed that the hazard ratio for congenital defects was 1.01 for the 26,424 women who took acetaminophen in the first trimester. 31 In a follow-up analysis, the hazard ratio for cryptorchidism was 1.38, but only with more than four weeks of regular acetaminophen use in the first and second trimesters. 32 Other, newer cohort studies have looked at the possible connection between acetaminophen use and attention-deficit/hyperactivity disorder and other hyperkinetic disorders. 33 , 34

The National Birth Defects Prevention Study (NBDPS), which analyzed data from 16,110 children in the United States exposed to acetaminophen in utero, found no increased risk of birth defects with acetaminophen use. In women using acetaminophen specifically for febrile illness, there were decreased risks of various cranial and facial defects and gastroschisis; acetaminophen may be protective because fever increases the risk of these defects. 35 A case series of 300 acetaminophen overdoses in pregnant women found no increased risk of congenital defects, stillbirth, or spontaneous abortions, regardless of trimester. At six weeks of life, the newborns had no evidence of hepatic or renal disease. 28 Many trials study acetaminophen in combination with cold remedies, rather than as a single agent, making causality difficult. The available information on acetaminophen use does not establish fetal risks; therefore, as a single agent, it is safe for use during any trimester, especially as single dosing without routine use.

A meta-analysis of aspirin use in the first trimester did not demonstrate an increased risk of congenital anomalies, except for gastroschisis (odds ratio [OR] = 2.37). 36 , 37 Early aspirin use at the time of conception or in the first several weeks of pregnancy does not increase the risk of spontaneous abortion. 38 Aspirin has been studied extensively as a treatment for many chronic disorders in pregnant women, including thromboembolism, antiphospholipid disease, and preeclampsia. There can be risks of intrauterine growth retardation and fetal and maternal hemorrhage in the third trimester. Overall, aspirin should be avoided during organogenesis and in the third trimester unless a physician specifically prescribes it and the patient understands the risks and benefits.

In a recent study, neither ibuprofen nor naproxen increased the risk of spontaneous abortion when used in the first six weeks of pregnancy. 38 A Swedish study of nonsteroidal anti-inflammatory drug (NSAID) use in early pregnancy did not demonstrate an increased risk of congenital anomalies overall; however, naproxen was associated with orofacial clefts, and all NSAIDs were associated with structural cardiac defects. 39 More recent data show a potential association between NSAID use and dextro-transposition of the great arteries, particularly in the first trimester. 29 NSAIDs are not recommended in the third trimester because of the risk of premature closure of the ductus arteriosus and subsequent primary pulmonary hypertension in the newborn. Because indomethacin (Indocin) is known to cause oligohydramnios and delay delivery, OTC NSAIDs are assumed to have the same risk. Although NSAID use is generally not recommended during pregnancy, women may ingest these medications inadvertently in many OTC combinations. Prolonged use of NSAIDs, including aspirin, should occur only for specific medical indications during pregnancy. Table 4 summarizes the safety of analgesics and antipyretics in pregnancy. 10 – 16

Enlarge Print

Table 4.

Safety of Over-the-Counter Analgesics and Antipyretics in Pregnancy

Medication

Drug class

Pregnancy risk category*

Crosses the placenta?

Use in pregnancy

Acetaminophen

Nonnarcotic analgesic/antipyretic

B

Yes

Drug of choice

Aspirin

Salicylate analgesic/antipyretic

C in the first and second trimesters, D in the third trimester

Yes

Should be avoided in pregnancy unless needed for specific indications

Naproxen

NSAID analgesic

C in the first and second trimesters, D in the third trimester [ corrected ]

Yes

Should be avoided in the third trimester

Ibuprofen

NSAID analgesic

C in the first and second trimesters, D in the third trimester

Yes

Should be avoided in the third trimester

NSAID = nonsteroidal anti-inflammatory drug.

*—Based on pregnancy risk category definitions from the U.S. Food and Drug Administration (Table 2) and other sources.

Information from references 10 through 16 .

Table 4.

Safety of Over-the-Counter Analgesics and Antipyretics in Pregnancy

Medication

Drug class

Pregnancy risk category*

Crosses the placenta?

Use in pregnancy

Acetaminophen

Nonnarcotic analgesic/antipyretic

B

Yes

Drug of choice

Aspirin

Salicylate analgesic/antipyretic

C in the first and second trimesters, D in the third trimester

Yes

Should be avoided in pregnancy unless needed for specific indications

Naproxen

NSAID analgesic

C in the first and second trimesters, D in the third trimester [ corrected ]

Yes

Should be avoided in the third trimester

Ibuprofen

NSAID analgesic

C in the first and second trimesters, D in the third trimester

Yes

Should be avoided in the third trimester

NSAID = nonsteroidal anti-inflammatory drug.

*—Based on pregnancy risk category definitions from the U.S. Food and Drug Administration (Table 2) and other sources.

Information from references 10 through 16 .

Herbals and Dietary Supplements

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

During pregnancy, herbal remedies are used for nausea, respiratory symptoms, urinary tract infections, pain, and other nonspecific issues. 40 However, there are few human data on the safety of herbal remedies in pregnancy. The Dietary Supplement Health and Education Act of 1994 requires manufacturers to ensure the safety of supplements before marketing. However, there is no registration process with the FDA, which takes action only if a supplement is found to be unsafe after marketing. 41 Herbals were not included in the NBDPS until the year 2000. According to a subanalysis of the NBDPS, 10.9% of women use herbals during pregnancy, most commonly peppermint, cranberry extract, herbal teas, ginger, chamomile, Echinacea, ginseng, raspberry leaf, and ephedra products. 42

St. John’s wort is generally not recommended in pregnancy because of a lack of human data. 42 , 43 Echinacea can be used topically or orally. A study with 112 women who used Echinacea in the first trimester showed no increased risk of malformations. 44 Feverfew is used for migraine prophylaxis. It inhibits platelet aggregation and prostaglandin production and is contraindicated in pregnancy. Multiple herbals, such as mugwort, blue cohosh, black cohosh, goldenseal, juniper berry, chaste berry, rue, and pennyroyal oil, are uterine stimulants or abortifacients and should be avoided in pregnancy. 45 Although ephedra is commonly used during pregnancy according to patient report, it has a significant association with birth defects. According to the NBDPS, ephedra is associated with anencephaly (OR = 2.8). 46 Other weight loss products, with or without ephedra, are associated with dextro-transposition of the great vessels and aortic stenosis. 46

Glucosamine has been used by pregnant women with painful arthritis and appears to be safe. In a case-control study of 54 women, there was only one major malformation in the glucosamine group, which was comparable to the baseline rate of birth defects, and there was no difference in the risk of stillbirth, abortion, preterm birth, or other maternal morbidity. 47 Ginger is commonly used in the first trimester and can be found in some prenatal vitamins. Although there have been concerns about ginger increasing the risk of spontaneous abortion or preterm delivery, this has not been demonstrated in animal studies. Two systematic reviews demonstrated that ginger improves pregnancy-related nausea more than placebo and as effectively as vitamin B6. Its effect on vomiting is less certain. No adverse effects have been noted for the mother or developing fetus. 45 , 48 Ginger is the only dietary supplement that can be recommended based on human studies. 45 , 48

Topical Creams

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Topical antifungals are commonly used during pregnancy for treatment of vulvovaginitis. Imidazoles and nystatin are well studied and considered safe during pregnancy. 49 – 51 Systemic absorption of imidazoles varies from 1% with miconazole to 10% with clotrimazole; nystatin is negligibly absorbed. Terbinafine (Lamisil) is sold OTC as a 1% cream. No studies are available for terbinafine cream; however, the oral form is pregnancy category B. 51

Hydrocortisone 1% is the only topical corticosteroid cream available OTC. Systemic absorption ranges from 1% to 7%, depending on the area treated and the underlying skin condition. 42 Although potent topical corticosteroids may have increased risks in pregnancy, the mild OTC forms are considered safe. As with all steroid use, the lowest dose used for the shortest time possible is recommended. 52

Smaller studies have not shown an association between use of the topical antimicrobial bacitracin and fetal malformations. 53 There are no studies regarding the safety of benzoyl peroxide use in pregnancy; however, the limited absorption of 5% suggests that it carries minimal risk. 42 Overall, topical OTC antifungal, antimicrobial, and steroid creams are safe in pregnancy.

Antacids and Antidiarrheals

Jump to section +

Abstract

Antihistamines

Decongestants

Expectorants and Antitussives

Analgesics and Antipyretics

Herbals and Dietary Supplements

Topical Creams

Antacids and Antidiarrheals

References

Heartburn occurs in up to 80% of pregnant women by the end of the third trimester. Antacids containing aluminum, calcium, or magnesium are often considered first-line treatment in pregnancy. However, at high doses, antacids containing calcium can cause milk-alkali syndrome, 54 and antacids with aluminum can cause neurotoxicity. Selective histamine H2 blockers have been used in all trimesters with no known teratogenic effects. In a meta-analysis of 2,398 women taking H2 blockers, the OR for congenital malformations was 1.14. 55

Proton pump inhibitors recently became available OTC. Although concerns have been raised about the potential teratogenicity of omeprazole (Prilosec), multiple large cohort studies have demonstrated its safety when taken before conception and during the first trimester. 56 In a meta-analysis of 1,530 infants exposed to proton pump inhibitors, the OR for congenital malformations was 1.12 overall and 1.17 for omeprazole alone, and there was no increased risk of preterm birth or spontaneous abortion. 57 In another study of proton pump inhibitor use in the first trimester (n = 5,082), the OR for birth defects was 1.10. Proton pump inhibitors and H2 blockers are considered safe in pregnancy. 58

Diarrhea and constipation are common during pregnancy. Products containing bismuth, mineral oil, and castor oil should be avoided. Bismuth itself is safe, but it has the same risks as aspirin when combined with salicylate. 59 In a study of 89 women, loperamide (Imodium) did not increase the risk of malformation, but was associated with smaller infants. 60 However, in a later study of 638 women, loperamide had an OR of 1.43 for congenital malformations. Although the American Gastroenterological Association considers loperamide to be low risk, it should be avoided when possible until further information is available. 59 , 61 Saline laxatives may cause electrolyte sodium retention and should be used sparingly. 62 Polyethylene glycol 3350 (Miralax) has minimal systemic absorption and is considered the drug of choice for chronic constipation despite a lack of research. 59 , 62 Table 5 summarizes the safety of OTC antacids, antidiarrheals, and laxatives in pregnancy. 10 – 16

Enlarge Print

Table 5.

Safety of Over-the-Counter Antacids, Antidiarrheals, and Laxatives in Pregnancy

Should be avoided in pregnancy, may interfere with absorption of fat-soluble vitamins§

Castor oil

Laxative/oxytocic

X

Not known

Should be avoided in pregnancy, potential for maternal/fetal morbidity

Polyethylene glycol 3350 (Miralax)

Osmotic laxative

C

Not known

Drug of choice for chronic constipation

FDA = U.S. Food and Drug Administration.

*—Based on pregnancy risk category definitions from the FDA (Table 2) and other sources.

†—Proton pump inhibitors as a class are rated FDA category B, including esomeprazole (Nexium), rabeprazole (Aciphex), and lansoprazole (Prevacid), based largely on animal data, which do not suggest any fetal risk; human data are limited.

‡—Hydrolyzes into bismuth salts and sodium salicylate in the intestinal tract. Sodium salicylate is not thought to suppress platelet function like the salicylate moiety found in aspirin; however, given the concerns over potential fetal toxicity from chronic salicylate exposure, avoidance in the latter half of pregnancy may be prudent.

§—The American Gastroenterological Association recommends avoidance presumably because of the risk of neonatal coagulopathy and hemorrhage arising from interference with maternal vitamin K absorption.

Information from references 10 through 16 .

Table 5.

Safety of Over-the-Counter Antacids, Antidiarrheals, and Laxatives in Pregnancy

Should be avoided in pregnancy, may interfere with absorption of fat-soluble vitamins§

Castor oil

Laxative/oxytocic

X

Not known

Should be avoided in pregnancy, potential for maternal/fetal morbidity

Polyethylene glycol 3350 (Miralax)

Osmotic laxative

C

Not known

Drug of choice for chronic constipation

FDA = U.S. Food and Drug Administration.

*—Based on pregnancy risk category definitions from the FDA (Table 2) and other sources.

†—Proton pump inhibitors as a class are rated FDA category B, including esomeprazole (Nexium), rabeprazole (Aciphex), and lansoprazole (Prevacid), based largely on animal data, which do not suggest any fetal risk; human data are limited.

‡—Hydrolyzes into bismuth salts and sodium salicylate in the intestinal tract. Sodium salicylate is not thought to suppress platelet function like the salicylate moiety found in aspirin; however, given the concerns over potential fetal toxicity from chronic salicylate exposure, avoidance in the latter half of pregnancy may be prudent.

§—The American Gastroenterological Association recommends avoidance presumably because of the risk of neonatal coagulopathy and hemorrhage arising from interference with maternal vitamin K absorption.

Information from references 10 through 16 .

Data Sources: We searched PubMed, UpToDate, the National Guideline Clearinghouse, and the Cochrane database using the terms over-the-counter, medicine, and pregnancy; herbals and pregnancy; and individual drug names in combination with pregnancy. Search dates: February to July 2012, July 2014.

The opinions herein are those of the authors. They do not represent official policy of the Uniformed Services University of the Health Sciences, the Department of the Air Force, or the Department of Defense.

Read the full article.

Get immediate access, anytime, anywhere.

Choose a single article, issue, or full-access subscription.

Earn up to 6 CME credits per issue.

Already a member/subscriber?

Log in >>

Purchase Access: See My Options close

Already a member or subscriber? Log in

Best Value!

Get Full Access

From $140

Subscribe

Includes:

Immediate, unlimited access to all AFP content

More than 130 CME credits per year

Access to the AFP app

Print delivery option

Access This Issue

$39.95

Includes:

Immediate access to this issue

CME credits in this issue

Access This Article

$20.95

Includes:

Immediate access to this article

To see the full article, log in or purchase access.

The Authors

show all author info

JESSICA SERVEY, MD, is an associate professor and assistant dean of faculty development at the Uniformed Services University of the Health Sciences, Bethesda, Md.…

JENNIFER CHANG, MD, is an assistant professor at the Uniformed Services University of the Health Sciences. She is also an attending physician at the Offutt Family Medicine Residency, Offutt Air Force Base, Neb.